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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH102358 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Boston Children's Hospital | OTHER |
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The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.
In this feasibility study, family dyads will participate in 12 sessions aimed at
Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALMS | Experimental | 12 session family therapy using multi-user biofeedback games |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CALMS | Behavioral | Family Therapy; Multi-user Biofeedback Videogames |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Percent of referred who consent and meet study criteria | Enrollment | Up to six months |
| Feasibility: Percent of 12 sessions completed | Engagement: Percent of sessions completed by consented and eligible participants | Up to six months |
| Feasibility: Counts of premature termination of intervention | Up to six months | |
| Feasibility: Self-report of Credibility/Satisfaction | Individual and family member self-report | 12 week assessment or last assessment completed |
| Feasibility: Self-report of User Experience | Self-report of ability to learn/use technology to lower stress reactivity | 12 week assessment or last assessment completed |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress relative to Baseline | Self-report via Perceived Stress Scale | Weeks 4, 8, and 12 Assessments |
| Change relative to Baseline in Youth Perceptions of Relationship with Family Member |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Woodberry, MSW, Ph.D. | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32237208 | Derived | Woodberry KA, Chokran C, Johnson KA, Nuechterlein KH, Miklowitz DJ, Faraone SV, Seidman LJ. Computer-aided learning for managing stress: A feasibility trial with clinical high risk adolescents and young adults. Early Interv Psychiatry. 2021 Jun;15(3):471-479. doi: 10.1111/eip.12958. Epub 2020 Apr 1. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Self-report of conflict, criticism, and warmth in relationship with participating family member
| Weeks 4, 8, 12 Assessments |
| Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult | Self-report of conflict, criticism, and warmth in relationship with youth | Weeks 4, 8, 12 Assessments |
| Positive Symptom Score Change relative to Baseline | Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS) | Weeks 4,8, and 12 Assessments |
| Change in Social and Role Functioning relative to Baseline | Global Functioning: Social & Role Scales; | Weeks 4, 8, and 12 Assessments |
| Change in Global Functioning relative to Baseline | SIPS Global Assessment of Functioning | Weeks 4, 8, and 12 Assessments |
| Safety: Change in Hostility/Aggression relative to Baseline | Self-report | Weeks 4, 8, and 12 |
| Safety: Change in Video-game Addiction relative to Baseline | Self-report | Weeks 4, 8, and 12 |
| Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task | Executive Control of Emotion | Baseline, Weeks 4,8, and 12 |